Accessibility Links

Technical Operations Engineer

  • Job reference: 926629
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 16/07/2019

Orion Group are looking for a Technical Operations Engineer for our multinational pharmaceutical client based in the Cork area on an initial 12-month contract with the potential to extend.

Job Purpose
The Technical Operations Engineer is a member of the Technical Operations (TO) Team with the dedicated focus on:

  • Continued Process Verification
  • Process Validation
  • Process Improvements
  • Leading complex cross functional investigations
  • Standards and new technology deployment

The Technical Operations Engineer is a key contributor to LCM and process improvement initiatives on the site.

Main Responsibilities of the role

  • Manage / execute the validation program related to LCM for existing products
  • Issue / review validation plan, protocols and reports
  • Be the site TO representative in LCM/NPI project teams as process / validation SME
  • As required coordination of LCM projects on site, under responsibility of global TO organization
  • Own / participate in the CPV program by issuing plans, protocols and reports and oversee execution
  • Lead complex investigations on the site by providing facilitation / technical expertise
  • Provides process / technology input to SOP's, Master Batch Records and change controls
  • Partner with Engineering & Maintenance and contribute to equipment changes / introduction projects on the site
  • Lead / support process improvement projects, including new technology / analytics introduction (e.g. MVA, PAT)
  • Contribute to Standardization initiatives for Technical Operations
  • Technical support / direct participation in partnership with Quality / Operations on any regulatory audits and inspection

Desired Experience and Background of the successful candidate

  • Honours degree in Engineering or Science, with minimum 5 years' experience in a pharmaceutical environment
  • Desirable candidate would have Master Degree or Equivalent with 5 - 8 years' experience in a pharmaceutical environment
  • Excellent social and communication skills
  • Self-driven and keeps up to date with regulatory, technical developments within the industry
  • Strong analytical and Problem Solving skills
  • Project management (FPX or other)
  • Excellent communication, written and oral
  • Acute attention to detail
  • Excellent team player with strong customer focus
  • Acute attention to detail
  • Focus on patients and customers at all times

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

Similar jobs
Material Engineering Project Lead
  • Salary Negotiable
  • Job type Contract
  • Location Cork
  • Description Orion Group Life Sciences have an exciting opportunity for a Materials Engineering Project Leader for our Multinational Medical Devices client based in the Cork region on an initial 12-month contract
EHS Specialist
  • Salary Negotiable
  • Job type Contract
  • Location Cork
  • Description Assists with the design, implementation, maintenance and review of Environmental, Health, Safety and Sustainability (EHS&S) programmes to ensure compliance with regulatory
Senior DSP Engineer
  • Salary Negotiable
  • Job type Permanent
  • Location Cork
  • Description Job Purpose The signal processing engineer is an information technologies expert that analyses and alters digital signals to make them more accurate and reliable